Effectiveness of a Pain Science Education Programme in Adolescent Students.

Not Applicable

Active, not recruiting

• Conditions: Pediatric ALL; Pain; Chronic Pain
• Interventions: Other: Pain Science Education

• Registration Number: NCT06060431
• Lead Sponsor: University Rovira i Virgili

Brief Summary

The aim of this study is to analyze the effectiveness of a Pain Science Education program to improve the conceptualization of pain in adolescents between 11 and 13 years old, schooled in the first year of Compulsory Secondary Education.

Detailed Description

Design:

Randomized controlled clinical trial. The primary endpoint of the study was pain conceptualization recorded by a questionnaire.

Setting:

The participants were school-age children attending a different high school in the province of Barcelona.

Participants:

Of the 450 potential school participants, 306 agreed to participate. 13 pupils were excluded when applying the eligibility criteria, so the resulting sample was of 293

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-09-30
• Status Verified: 2023-09
• Study First Submitted: 2023-09-18
• Study First Submitted QC: 2023-09-23
• Last Update Submitted: 2023-09-23
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 293

Inclusion Criteria

• to be schooled at the El Cim school
• to be between 10 and 16 years old (both included)
• to have or have had pain in the last month; to be able to read and write in Catalan and/or Spanish.

Exclusion Criteria

• had an intellectual disability and/or cognitive impairment that interfered with their participation
• had not submitted the informed consent form duly completed and signed by their legal guardians

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Pain Science Education	The experimental group will carry out the sessions of the specific Pain Sciences program. This intervention is based on two educational sessions of 90 and 60 minutes each, separated by one week.

Primary Outcome Measures

Name	Time	Method
Conceptualization of Pain Questionnaire (COPAQ)	1 year	The Conceptualization of Pain Questionnaire (COPAQ) consist of 15 items and asks respondents to respond if they believe the items/statements to be true or false, although they are allowed to respond undecided. A score of 0 is given to incorrect responses and those marked as undecided; the sum of all the correct answers gives the total score. The higher the score, the better the participant understands the concept of pain.

Trial Locations

Locations (1)

Laura Menés Fernández; 🇪🇸 Vilanova i la Geltrú, Barcelona, Spain